Therapy Areas: Devices
Rapid Medical wins US FDA approval for novel temporary aneurysm embolization assist device, Comaneci
8 May 2019 -

Neurovascular devices company Rapid Medical revealed on Tuesday the receipt of US FDA clearance for the Comaneci device under the new temporary coil embolization assist devices category.

The company added that the Comaneci device, which is the first and only device in a new temporary coil embolization assist devices category, is the first-ever adjustable, fully-visible aneurysm remodelling device. It acts as a temporary bridge used to aid in the coiling processes while minimising the risk of coil protrusion or prolapse.

According to the company, the Comaneci device is the only temporary coiling assist device that does not require parent vessel occlusion during coiling procedure or the need for long-term antiplatelet medication in case of permanent stenting. It is the only non-vessel-occluding temporary intracranial coiling embolization assist device.

To date, the Comaneci have been successfully used in about 3,000 procedures outside the US, concluded the company.